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[精神科医生开具通用名、品牌名及未标注适应症药物处方的职业责任]

[Psychiatrist's professional liability for generic, brand, and off-label drug prescription].

作者信息

Nivoli Giancarlo, Lorettu Liliana

机构信息

Società Italiana Psichiatria Forense.

出版信息

Riv Psichiatr. 2013 May-Jun;48(3):215-23. doi: 10.1708/1292.14289.

Abstract

At present, drug prescription is a hot topic in terms of professional responsibility. Psychiatric-forensic criteria are provided for appropriate drug prescription, focusing on off-label and generic drug prescription. Off-label prescription should be made in accordance with current regulations, in particular with the regulatory requirements related to patient consent. Generic drug prescription is affected by several critical issues, such as drug excipients, equivalence to original drug, correspondence of therapeutic indications. The different spheres of responsibility of physicians and apothecaries in prescribing and distributing drugs, respectively, are discussed. The knowledge of these issues can be helpful for physicians in their clinical practice, allowing preservation of professional autonomy and compliance with current regulations. The explanation of the most common mistakes about drug prescription that are examined in law courts can be the starting point of an interdisciplinary debate involving all interested parties that are called upon to judge psychiatrist responsibility in drug prescription.

摘要

目前,药物处方在专业责任方面是一个热门话题。针对适当的药物处方提供了精神科法医标准,重点关注非标签用药和仿制药处方。非标签用药应符合现行法规,特别是与患者同意相关的监管要求。仿制药处方受到几个关键问题的影响,如药物辅料、与原研药的等效性、治疗适应症的对应性。分别讨论了医生和药剂师在药物处方和分发中的不同责任范围。了解这些问题对医生的临床实践有帮助,有助于保持专业自主性并遵守现行法规。对法庭上审查的关于药物处方最常见错误的解释,可以成为涉及所有被要求评判精神科医生药物处方责任的相关方的跨学科辩论的起点。

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